Conference organized by:

Center for Biosecurity of UPMC

World Health Organization Communicable Disease Surveillance and Response Office

Conference sponsored by:

The Nuclear Threat Initiative

Biosafety: What are the different levels and what is the continuum?
Presenter: Jonathan Richmond, Ph.D.

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Mr. Richmond, a former Director of CDC's Office of Health and Safety, outlined the key objectives, elements and, in some cases, challenges of building a comprehensive laboratory biosafety program, the importance of which has increased as the number of high-hazard, high-containment laboratories and their attendant accidental releases and laboratory accidents have multiplied globally. He first distinguished between biosafety and biosecurity, describing them as two related but different goals. Biosafety is directed at "reducing or eliminating accidental exposure to or release of potentially hazardous agents" in the laboratory, while biosecurity is focused on "protecting against theft or diversion of select agents" from a laboratory for "nefarious" uses. While he defined a "Responsible Scientist" as an individual who should be held responsible for day-to-day conformance of their laboratory to established biosafety norms, Richmond pointed out that accountability itself may be viewed differently in different cultures.

The concept of four biosafety levels (BSL-1 to BSL-4), which was introduced in the mid-1970's, is a framework adopted by the CDC in the late 1970s and by the WHO in the early 1980s. Each level provides for correspondingly higher safety expectations for the experience and responsibilities of a "responsible scientist," for program requirements and staff training, and at the highest levels, for employee health surveillance and self-assessment, along with rigorous safety engineering. A designated level of needed safety protection is based on a risk assessment, which must be science-based and conducted by the most knowledgeable individual on a team (e.g., the principal investigator). While a number of challenges exist for establishing a sound biosafety program (e.g., risk assessment, facility design, personnel hiring), the most fundamental one is creating a suitable "biosafety culture" that reflects responsible behavior at all levels of an organization. Richmond emphasized that establishing that shared value requires the support of top management. Government failure to adapt standardized biosafety guidelines that would better steer the efforts of the scientific community has created another challenge.

Consistency requires uniform guidelines and program self-assessments; to this end, Richmond has developed self-assessment criteria based on the guidelines that can be applied to laboratory operations. He concluded by discussing the role and functions of the Biological Safety Officer and Safety Committee, and how risk assessment, supported by these functions, is ultimately directed at breaking the �chain of infection� in a laboratory environment.

- Summary by Joseph Fitzgerald, M.H.S., M.P.H. 

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